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Author: Mark RoggePublisher: CRC PressISBN: 1420084739Format: PDF, DocsDownload Now
Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: Pharmacokinetics Modeling and simulation Formulation and routes of administration Toxicity evaluations The assessment of drug absorption and metabolism Interspecies scaling Lead molecule selection and optimization via profiling Screening using in silico and in vitro toxicity evaluations The book also includes case studies on preclinical pharmacokinetic-pharmacodynamic modeling and simulation in drug development, a review of ICH preclinical guidelines, and experimental methods used to study membrane drug transport and metabolism. This guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.

Author: Donald MonkhousePublisher: CRC PressISBN: 082475462XFormat: PDF, ePub, DocsDownload Now
Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

Author: Hui KimkoPublisher: CRC PressISBN: 9780203910276Format: PDF, KindleDownload Now
Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to clinical trial designs according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.

Author: Sarfaraz K. NiaziPublisher: CRC PressISBN: 1482226375Format: PDF, ePub, MobiDownload Now
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Author: Allen CatoPublisher: CRC PressISBN: 0824744802Format: PDFDownload Now
Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Author: Jennifer B. DressmanPublisher: CRC PressISBN: 0824741986Format: PDF, DocsDownload Now
A practical, hands-on guide for successfully developing oral drug products, this comprehensive reference runs the gamut from theoretical stages of computer-based calculations to practical guidelines for establishing in vitro/in vivo correlations. Coverage details the interrelationship between the physiology of the gastrointestinal tract and oral drug formulations and absorption, and progresses to the latest applications of pharmacokinetic analysis. Includes chapters by the innovators of the Biopharmaceutical Classification Scheme (BCS), human perfusions, and biorelevant dissolution testing! With over 600 literature references, equations, drawings, and photographs, Oral Drug Absorption offers multiple methods for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence facilitates selection of appropriate drug candidates for development fully elaborates on the experimental and data analysis techniques of in vitro/in vivo correlations provides guidance to the Federal Drug Administration's BCS and its applications appends helpful case studies to the concepts discussed and much more! Contributions by more than 20 international specialists on the latest research make Oral Drug Absorption an invaluable tool and useful reference in the hands of pharmaceutical scientists, medicinal chemists, pharmacists, pharmacologists, toxicologists, biochemists, gastroenterologists, regulatory personnel, and graduate school students in these disciplines.

Author: Steven W. BaertschiPublisher: Taylor & Francis USISBN: 0849359198Format: PDF, KindleDownload Now
The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

Author: Leon ShargelPublisher: CRC PressISBN: 1420086367Format: PDF, MobiDownload Now
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

Author: Tom BrodyPublisher: Academic PressISBN: 0123919134Format: PDF, ePubDownload Now
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn